Hygienic Filling Machines for the Food Industry Quality ...

VDMA Documents Food Processing Machinery and Packaging Machinery

Hygienic Filling Machines for the Food Industry Quality Assurance and Maintenance Checklist No. 3/1997 (2nd edition 2008) January 2008, English edition September 2008

Verband Deutscher Maschinen- und Anlagenbau e.V.

Fachverband Nahrungsmittelmaschinen und Verpackungsmaschinen Vorsitzender: Volker Kronseder Geschäftsführer: Richard Clemens

Lyoner Straße 18 D-60528 Frankfurt am Main Telefon +49 69 66 03-14 31 Telefax +49 69 66 03-12 11 E-Mail [email protected] Internet www.vdma.org/packtech

VDMA Wir, die Investitionsgüterindustrie

Hygienic Filling Machines for the Food Industry Quality Assurance and Maintenance Checklist

© Fachverband Nahrungsmittelmaschinen und Verpackungsmaschinen, Seite 2/32 Lyoner Strasse 18, 60528 Frankfurt, September 2008

Contents Preface to the second edition .................................................................................................................................................................................................................4 1 Introduction......................................................................................................................................................................................................................................4 2 General requirements on the environment of the machine location ...............................................................................................................................................5

2.1. Roomhygiene ...........................................................................................................................................................................................................................6 2.2. Personal hygiene......................................................................................................................................................................................................................6

3 Checks prior to commissioning .......................................................................................................................................................................................................7 4 Quality-maintenance measures and checks prior to production .....................................................................................................................................................8

4.1 Packaging materials .................................................................................................................................................................................................................8 4.2 Operating resources.................................................................................................................................................................................................................8 4.3 Product being filled.................................................................................................................................................................................................................11 4.4 Maintenance / Repairs ...........................................................................................................................................................................................................11 4.5 Functional testing ...................................................................................................................................................................................................................11 4.6 Cleaning .................................................................................................................................................................................................................................11 4.7 Cleaning checks.....................................................................................................................................................................................................................11 4.8 Sterilization of machine / check on sterilization .....................................................................................................................................................................12 4.9 Check on empty package for residues of sterilization medium..............................................................................................................................................12

5 Quality-maintenance measures and checks during production ....................................................................................................................................................13 5.1 Machine settings ....................................................................................................................................................................................................................13 5.2 Emissions ...............................................................................................................................................................................................................................13 5.3 Sampling ................................................................................................................................................................................................................................13 5.4 Inspection of packaging during production ............................................................................................................................................................................13 5.5 Measures to be taken when production is interrupted ...........................................................................................................................................................13

6 Quality-maintenance measures and checks after end of production ............................................................................................................................................15 6.1 Cleaning/sterilization ..............................................................................................................................................................................................................15 6.2 Machine inspections...............................................................................................................................................................................................................15 6.3 Packaging materials/auxiliary packaging materials ...............................................................................................................................................................15 6.4 Documentation .......................................................................................................................................................................................................................15

7 Examination of production result ...................................................................................................................................................................................................16 7.1 Sampling ................................................................................................................................................................................................................................16 7.2 Check of package...................................................................................................................................................................................................................17 7.3 Testing the finished product ...................................................................................................................................................................................................17 7.4 Identification of sporadic faults...............................................................................................................................................................................................17

8 Quality-maintenance measures in the event of operating malfunctions .......................................................................................................................................18 8.1 Potential hazards....................................................................................................................................................................................................................18 8.2 Recommended actions in the event of a fault........................................................................................................................................................................18



8.3 Documentation .......................................................................................................................................................................................................................19 8.4 Training ..................................................................................................................................................................................................................................19

9 Maintenance measures .................................................................................................................................................................................................................20 9.1 Organizational measures .......................................................................................................................................................................................................21

9.1.1 Responsibilities ...............................................................................................................................................................................................................21 9.1.2 Maintenance plan............................................................................................................................................................................................................21 9.1.3 Operations planning........................................................................................................................................................................................................22 9.1.4 Documentation................................................................................................................................................................................................................22 9.1.5 Updating of the maintenance plan ..................................................................................................................................................................................22

9.2 Operating materials and spare parts......................................................................................................................................................................................22 9.3 Cleaning / Sterilization ...........................................................................................................................................................................................................22 9.4 Sterile test ..............................................................................................................................................................................................................................22

10 Cleaning/Sterilization .................................................................................................................................................................................................................23 10.1 Cleaning and sterilizing the aseptic packaging machine....................................................................................................................................................23 10.2 Unscheduled cleaning or sterilization.................................................................................................................................................................................24 10.3 Cleaning documentation.....................................................................................................................................................................................................24

11 Documentation...........................................................................................................................................................................................................................25 11.1 Documentation of tests carried out prior to production.......................................................................................................................................................25 11.2 Documentation of tests carried out during and after production ........................................................................................................................................25 11.3 Cleaning documentation.....................................................................................................................................................................................................25 11.4 Documentation of tests carried out for subsequent quality control of the finished product and packaging .......................................................................25 11.5 Documentation of operating malfunctions ..........................................................................................................................................................................25 11.6 Systematic recording of customer complaints....................................................................................................................................................................25 11.7 Documentation of maintenance and repair measures undertaken ....................................................................................................................................25 11.8 Change documentation ......................................................................................................................................................................................................25

12 Training .....................................................................................................................................................................................................................................26 12.1 Machine staff ......................................................................................................................................................................................................................26 12.2 Maintenance staff ...............................................................................................................................................................................................................27 12.3 QA (quality assurance) staff ...............................................................................................................................................................................................27 12.4 Management staff ...............................................................................................................................................................................................................27

13 References.................................................................................................................................................................................................................................28 Appendix: Hygienic filling – Summary of factors relevant to quality .....................................................................................................................................................30 This checklist is the English translation of a publication which was drawn up by the Working Party for "Interface Problems in Aseptic Plants" of the VDMA technical department for packaging machines. It is available as a download from WWW.VDMA.ORG/PACKTECH. Suggestions for changes and additions may be sent to the following address: Fachverband Nahrungsmittelmaschinen und Verpackungsmaschinen at VDMA, Lyoner Straße 18, 60528 Frankfurt/M., Fax: +49 69/6603-1211.



Preface to the second edition The first edition of the Quality Assurance and Maintenance Checklist was published in Verpackungsrundschau in 1997. Since then the checklist has been used not only in the field of aseptic filling machines – hygienic filling machines of VDMA class V – but also in lower level hygiene classes1. In the course of work on VDI-Richtlinie (VDI Guideline) 4066 it was decided to revise the checklist to include passages reflecting its use for lower level hygiene classes. Furthermore, in the course of revision references to the literature and legal provisions were updated and the trade association publications published following the drawing up of the first edition by the VDMA Working Party for Interface Problems in Aseptic Plants were incorporated. To the extent that for individual sections of this checklist dedicated chapters are elaborated in VDI-Richtlinie 4066 reference is made to this guideline in the corresponding sections.

1 Introduction The filling process is the last step of production and at the same time the first step of the packaging process. It therefore represents a critical interface within the production process, because it determines whether and for how long the original quality of the foodstuff can be retained along distribution routes intended for it. Particular care concerning factors affecting quality has long been exercised in aseptic filling processes in which a commercially sterile product is packaged without recontamination in a sterilized packaging material. Since it is virtually impossible using such machines to determine defects in the microbiologically relevant functions by means of methods of analysis based on random sampling, the only way to ensure microbiologically safe production is the consistent implementation of precautionary measures for preserving quality. Nevertheless, even in the case of nonaseptic filling, high demands have to be imposed on filling hygiene and precautionary measures for retaining quality if the storage life expected by the market is to be attained for perishable products in which preservatives and secondary thermal treatment are largely unused. The present publication assembles in the form of a checklist those factors which have proved in practice to be relevant to quality. Apart from cleaning, sterilization and maintenance tasks as well as machine checks and classical quality tests, a chapter dealing with the machine environment and training of personnel has also been included. The significance of the influencing factors listed in these chapters for the microbiological safety of the production process is often underestimated in practice. The present checklist is intended at the same time to be an aid for implementing the HACCP2 iconcept in filling plants as required under EC Ordinance No. 852/2004 concerning food hygiene in relation to consumer health protection.

1 In VDMA Document NuV No. 2 (2nd edition 2006) five hygiene classes for filling machines are defined. 2 HACCP: Hazard Analysis Critical Control Point Hazard to health Analysis of the hazard Critical with respect to control of the process Control including monitoring of the production process Point step in the process HACCP is described, for example, in the Codex Alimentarius and in EC Ordinance No. 852/2004 on food hygiene.



2 General requirements on the environment of the machine location When it is considered that during filling the product necessarily comes into contact with its environment it is clear that the installation location has a decisive influence on the microbiological quality of the packaged product. The packaged goods can of course be shielded from environmental effects by machine-related measures such as sterilization of the packaging material, covering the filling section and blanketing it with sterile air. By this means, however, the factors favoring microbiological contamination are only diminished but not completely eliminated. Accordingly, it is always recommended that the preconditions for hygienically sound filling be created as early as the planning and construction phases. If a filling machine is set up in an existing environment the latter should be critically examined from the hygiene point of view and shortcomings eliminated as far as possible prior to installation of the filling machine. On the subject of planning and installation errors the VDMA Working Party for "Interface Problems in Aseptic Plants" has published a separate booklet3 4. VDI Guideline 4066 deals extensively with the planning of filling plants and with the design of the surroundings of the machine location. Accordingly, at this point reference to the extensive keyword lists in EC Ordinance (ECO) No. 852/2004, Appendix II, and EC Ordinance 853/2004, Appendix III, Section IX, should suffice. The observations relate to practical experience in aseptic filling but can largely be transferred to nonaseptic filling when a high level of microbiological quality of the filled product is to be obtained.

3 4 VDMA FS NuV No. 4 (2002)



Keywords Notes 2.1. Roomhygiene

e.g. • Composition of floor (ECO No. 852/2004, Appendix

II, Chapter III) • Wall cladding (ECO No. 852/2004, Appendix II) • Ventilation (ECO No. 852/2004, Appendix II,

Chapter I) • Drainage (ECO No. 852/2004, Appendix II) • Devices for cleaning and disinfecting operating

equipment (ECO No. 852/2004, Appendix II) • Room lighting (ECO No. 852/2004, Appendix II) • Spatial separation from wrapping and packaging

(ECO No. 852/2004, Appendix II)

In addition to the fundamentals as listed in the European directives, the following requirements have emerged in practice inter alia: • Checking product and supply lines for planning and installation errors5 • Avoidance of formation of condensate on piping • No machines to be set up over drains! • Adequate frequency of air change (at least twofold to max. fivefold air change per hour, the latter in the

case of high contamination levels) • When designing the ventilation system the emission of vapors (e.g. H2O2, peracetic acid) into the room

from finished packages should also be considered (in the case of sterilization of packaging materials by H2O2 or peracetic acid)

• The installations are to be designed structurally in such a way that no vapors escape into the surrounding air and maximum allowable workplace concentrations are adhered to

• No through-traffic in production rooms housing aseptic machines! • Filling and outer packaging processes should be performed in separate rooms in order to keep the dust

load in the filling room at a low level • Pallets must not be stored in production rooms • Piping and horizontal surfaces should be installed in such a way as to allow simple external cleaning • Minimization of the risk of microbial contamination (contamination pressure) through such effects as draughts, supply of unfiltered air (open windows!), through-traffic (forklift trucks!), visitor groups

2.2. Personal hygiene • Health certificate, e.g. in the dairy industry (in

accordance with the Infection Act) • Clothing, headgear (ECO 852/2004, Appendix II,

Chapter VIII) • Washing facilities (ECO 852/2004, Appendix II,

Chapter I) • Disinfection of hands • Training in hygiene (ECO 852/2004, Appendix II,

Chapter XII)

The contamination of packaging material webs or cups by the machine operators is a weakness encountered in practice. Making staff aware of this problem by appropriate training and the provision of washing facilities as well as disinfectants in the immediate vicinity of filling machines are considered preconditions for reliably ruling out this source of errors. This aspect also includes the regular renewal of health certificates. In connection with personal hygiene psychological factors should not be underestimated. Distinguishing between hygiene zones and the wearing of special clothing prior to entering the hygiene area demonstrably arouse hygiene consciousness.

5 A compilation of typical planning and installation errors together with case studies is provided in VDMA Document FS NuV 4/2002.



3 Checks prior to commissioning Before being commissioned or put into operation, filling machines of hygiene classes IV and V are normally checked to see whether they are suitable for the proposed use. A distinction is made between the validation6 of the machine functions (validation testing) and acceptance of the machinery at the customer's works (commissioning testing)7. As part of the validation of machine functions it is, for example, checked – often once through on a basic machine of equivalent functionality - whether the microbiological functions of the packaging machinery satisfy the minimum requirements for filling machines of VDMA hygiene classes IV or V, as set out, for instance, in the VDMA Documents FS NuV 11/2006 and FS NuV No. 10/2005. The results of these validation tests have been documented and can be made available to the user for verification, e.g. in the course of the machine acceptance test8. Validation also includes testing the suitability of the packaging materials specified for filling on class IV or class V machines. In particular containers having difficult geometries and multipart closures should be investigated from this point of view with regard to their sterilizability and if need be optimized. Critical factors for sterilization should be explicitly mentioned in the specification of the packaging material so that if need be these can be incorporated into quality control. Tests to be performed during the commissioning testing procedure are to be compiled by the machine user jointly with the machine manufacturer. These are used inter alia for: • checking that installation has been done properly • checking on compliance with legal limits (airborne noise, electromagnetic compatibility, waste water, maximum allowable workplace concentrations9 • performance if need be of a sterile test (in the case of machines of hygiene classes IV and V)10 • checking on performance pledges made by the machine manufacturer • checking on the reliable exclusion of hazards as established during a preceding hazard analysis. It is to be noted that the test results may depend on the product to be processed. When changing the product a new hazard analysis is recommended in the case of products which have not yet been examined. If necessary, an acceptance test of the machine should be performed for the new product.

6 Validation: Confirmation by provision of objective proof that the requirements for a specific intended use or a specific intended application have been fulfilled (DIN EN ISO 9000: 2005/3.85 7 In connection with this see EHEDG Subgroup Packing Machines (2000): Challenge tests for the evaluation of hygienic characteristics of packing machines for liquid and semi-liquid products. This publication includes citations of test methods for checking machine functions in the course of validation testing and commissioning testing. EHEDG: European Hygienic Equipment Design Group 8 The VDMA Working Party for Interface Problems in Aseptic Plants has published several association documents on the subject of checking the microbiological functions of filling machines. These relate to the sterilization of packaging materials (VDMA FS NuV No. 6), the sterilization of the sterile area in the interior of the machine (VDMA FS NuV No. 8) and the external sterilization of packaging materials (VDMA FS NuV No. 14) 9When chemical sterilization media are employed the process should be carried out with the installations closed in order to comply with workplace threshold values 10 A specification of a sterile test may be found in VDMA Document FS NuV 12/2007



4 Quality-maintenance measures and checks prior to production Before production is started the machine operator must satisfy himself of the proper condition of the machine. For this, suitable checklists should be available to him. The machine should preferably be constructed in such a way that deviations from the desired state are automatically and independently reported. Tests carried out as well as any deviations from the required state should be documented in an appropriate way. Keywords Notes 4.1 Packaging materials

• Agreement with specification • Storage • Visual inspection for mechanical damage • Visual inspection for soiling

Use of packaging materials in line with specification is essential for the troublefree operation of the filling machine. In the case of filling machines of hygiene classes IV and V particular care has to be taken that the specification criteria identified as critical for the sterilizability of the packaging materials in the course of validation are adhered to. Packaging materials to be processed in aseptic machines must additionally satisfy high microbiological demands. With regard to the permissible initial microbial count for packaging materials there are no legally binding specifications. A working group of the IVLV has drawn up guide values for sheet packaging materials and containers and in doing so also dealt with the microbiological test methods needed for this purpose11. The packaging material and containers should be stored in accordance the manufacturer's instructions in order to prevent damage, contamination and adverse climatic effects. It should be ensured by precautionary hygienic measures that additional microbial contamination of the packaging material is restricted to the unavoidable minimum (see Chapter 2).

4.2 Operating resources

Prior to the start of production, the resource connections of the machine are to be checked with regard to the following criteria: • quality according to requirements • amount provided (e.g. adequate line pressure) • correct connection

• Electric power Type of power: Frequency: Voltage: Current strength:

11 Information about this may be found on the IVLV website under the following link: http://www.ivlv.de/d/projekte.html?page=prj&prjid=500&jahr=2007&wgrpid=2. The project is run under the scientific care of the Fraunhofer IVV in Freising, contact: Dr. W. Hennlich (tel.: +49(0)8161-491 625; [email protected]



Keywords Notes Connected load: Consumption: Cross section of main feeder cable:

• Cooling water/Purge water Microbiological quality according to applicable drinking water ordinance (TrinkwV) Inlet temperature: ≤ 20 °C Inlet pressure: according to specification Water hardness: ≤ 8° dH pH: 5.0-8.0 Cooling-water return (option)

The water hardness has a decisive effect on the long-term serviceability of the cooling system. Accordingly, if there are deviations from the recommended degree of hardness the machine manufacturer should be consulted.

• Ice water Microbiological quality according to applicable drinking water ordinance (TrinkwV) (for primary circuits only) Inlet temperature: ≤10° C Inlet pressure: according to specification Water hardness: ≤ 8° dH pH: 5.0 - 8.0 Ice water return

• Steam: Food quality (required when used for sterilization) Filtered Adequate removal of water Inlet pressure: according to specification

The pressure and associated temperature as well as moisture content of the steam used for sterilization must conform to the data provided by the machine manufacturer to ensure that the automatic SIP (Sterilization in Place) programs reliably achieve the necessary degree of sterilization.

• Compressed air: Max. particle size: 20 μm Max. particle qty: 25 mg/m3

The incoming compressed air after treatment (e.g. sterile filtration) can be used as a basis for the sterile air required in the machine (depending on system)



Keywords Notes Dew point: ≤ 2 °C Inlet pressure: according to specification Oil-free Neutral in taste

• Sterilization agent: Food quality Concentration: according to specification Temperature stability: according to specification

The concentration and purity of the sterilization agent employed (e.g. H2O2)12 must conform to the data provided by the machine manufacturer to ensure that the automatic SIP (Sterilization in Place) programs as well as the packaging sterilization reliably achieve the required degree of sterilization. Hydrogen peroxide solution should be stored protected from light and at temperatures of less than 15 °C unless the solution contains a stabilizer (cf. DAB 10)13. Any additives in sterilization agents should be food-compatible. Manufacturer's data to be observed for dosing.

• Detergents: Suitability according to cleaning instructionsConcentrations: according to specifications Max. chloride ion content (as per DIN 11 483, Part 1, Para. 4):

The cleaning instructions agreed with the machine manufacturer are matched to the specified concentration of detergent. Any deviations from the specifications adversely affect the cleaning result and increase the risk of corrosion. It is recommended that blended detergents ( = cleaning agents blended by the manufacturer) be used.

12 H2O2: Hydrogen peroxide 13 DAB: Deutsches Arzneibuch (German Pharmacopeia)



Keywords Notes 4.3 Product being filled

• Pressure • Temperature • Viscosity • Particles • Surface tension • Fiber admixture • Air inclusions • Electric conductivity • pH • Salt content • Microbiological requirements • Product homogeneity (degree of mixing and

stability of homogeneity)

Checking of the specified criteria only in so far as required by the product characteristics.

4.4 Maintenance / Repairs

Check on whether scheduled maintenance or necessary repair work has been performed (see also Chapter 9).

4.5 Functional testing

The machine functions critical for hygienic production are to be checked prior to production. This can be performed by automatic self-testing of the machine or manually. Any functional deficiencies are to be documented and to be corrected before production is started

4.6 Cleaning • CIP cleaning of product route • Cleaning of splash zone • Machine parts cleaning • External cleaning of machine • Cleaning of surroundings

Cleaning is to be performed according to the cleaning instructions agreed with the machine manufacturer. Care has to be taken to use a suitable detergent (see also Chapter 10). Cleaning should be adequately documented. Automatic documentation of the key cleaning parameters (see 4.7) is recommended for machines of hygiene classes IV and V. Machine cleaning should preferably be done automatically (CIP).

4.7 Cleaning checks

CIP cleaning • Review of major cleaning parameters, such

as cleanant flow rates, cleaning times, cleaning cycles, temperatures of cleaning media, cleaning pressures, concentrations of cleaning media

Successful cleaning presupposes that the specifications agreed with the machine manufacturer are observed for the key cleaning parameters. A corresponding chapter of VDI Guideline 4066 is devoted to the subject of external cleaning.



Keywords Notes • Visual inspection of mechanical

effectiveness of cleaning (according to cleaning instructions)

External cleaning of the machine

4.8 Sterilization of machine / check on sterilization14 • Sterile chamber • Product pathway • Check on filters (in particular sterile filters)

Successful sterilization presupposes successful cleaning. The sequence of the sterilization process has to be checked. Any deviations in respect of temperature, pressure, time or quantity of sterilization agent are to be documented. If necessary, sterilization must be aborted and repeated. After sterilization up to the start of production the operator must not make any interventions in the sterile chamber which adversely affect the sterility of the sterile chamber.

4.9 Check on empty package for residues of sterilization medium

Dependent on process, in accordance with manufacturer's instructions. VDMA Document NuV No. 1 (2000) contains test procedures for this.

14 If necessary



5 Quality-maintenance measures and checks during production Keywords Notes 5.1 Machine settings To ensure proper and aseptic production all key operating parameters must be compared with the

respective target values during production. For this purpose aseptic packaging machines must be: • equipped with measuring devices to the extent that all variables of state of importance for safe

operation in the packaging machine can be adequately measured and controlled; • equipped with control devices relating to the packaging machinery to the extent that proper operation

independent of interfering variables is ensured (e.g. control of packaging material sealing); • equipped with control and safety devices to the extent that all operating disturbances in the packaging

machine affecting product quality are displayed or intervention for corrective action is initiated. The measuring, control, and safety devices must be protected against unauthorized intervention. (Formulated on the basis of Section 2.3 of Test Directive No. (3) of the Committee on Heaters at the Bundesanstalt für Milchforschung (Federal Institute for Milk Research), Kiel, Germany.) Unless the necessary checks and the documentation of deviations from specified target values ensue automatically, test instructions and suitable checklists must be given to the machine operator. For filling machines of hygiene classes I to IV lower requirements with respect to health protection are imposed on the automatic monitoring of operating parameters. Nevertheless control of the operating parameters related to the hygiene quality of the product is recommended. This may, but not necessarily, ensue automatically. In the event of automated control suitable process instructions should be drawn up in collaboration with the machine manufacturer.

5.2 Emissions • MAC values (e.g. emission of the sterilizing

agent into the room)

Legal regulations and limit values must be observed15. Any further emissions, such as airborne noise, electromagnetic compatibility (EMC), and sewage or waste water should be examined, where necessary, as part of the commissioning test (see Chapter 3). Checks accompanying production are not possible as a rule or are not necessary.

5.3 Sampling In accordance with the plant operator's sampling plan (see also Section 7.1) 5.4 Inspection of packaging during pro-

duction To allow malfunctions to be detected as early as possible simple tests should be carried out directly during the sampling process (as a rule by the machine operator). (This may include testing for leaks, testing for sterilization agent residues in the product, and testing for the correct fitting of packaging attachments.)

5.5 Measures to be taken when produc- Manufacturer's instructions should be observed.

15 Information on international maximum allowable concentrations is provided by the GESTIS database, International limit values for chemical agents, which under the aegis of the Gefahrstoffinformationssystem (Hazardous substance information system) GESTIS is available for research at no cost under the following link: http://www.hvbg.de/e/bia/gestis/limit values/index.html.



Keywords Notes tion is interrupted

In the case of hygienic filling machines of classes IV and V production stoppages should be safeguarded in such a way that the sterile state of the machine is not altered or the need to clean and sterilize the machine is indicated to the operator.



6 Quality-maintenance measures and checks after end of production Keywords Notes 6.1 Cleaning/sterilization

• Cleaning/sterilization of product-handling parts as well as of the sterile section of the machine

• External cleaning and, where applicable, disinfection

• Cleaning of machine surroundings

Cleaning and, if needed, sterilization in accordance with the cleaning plan to be drawn up by the plant operator in agreement with the machine manufacturer.

6.2 Machine inspections • Filling levels of operating resources to be read

off and documented • Consumption values to be determined • Disposal of operating resources where

applicable

Systematic machine inspections make the identification of irregularities easier and thus help determine any functional faults at an early stage.

6.3 Packaging materials/auxiliary packaging materials • Preventive measures against soiling of

packaging material (e.g. covering and, if need be, storage)

Low microbial counts and dirt soiling on the packaging material is a major precondition for ensuring the aseptic operation of the packaging machine. Even in nonaseptic filling soiling of the packaging material is one source of malfunctions and microbiological contamination of product.

6.4 Documentation • Cleaning / Sterilization • Production record

among other things evaluation of fault reports, notes on extraordinary events, documentation of consumption values and operating parameters of the plant, name and signature of machine operator

In the case of unsterility production records are important documents in aseptic filling. They can be used to diagnose the cause of the problem. In the case of nonaseptic filling production logs are also helpful for recognizing the causes of possible quality and hygiene problems.



7 Examination of production result Keywords Notes 7.1 Sampling

Sampling is performed according to a specified sampling plan, which defines who is to take which samples in what quantities and how often.

• Product being filled So that in the case of unsterility of packages possible causes may be narrowed down, the possibility of sampling immediately upstream the interface between the process system and the packaging machine appears sensible. Such a sampling point itself, however, is a further unsterility risk. Since additionally due to the low sample volume no reliable results are to be expected setting up such a sampling point is not recommended. The only possibility of reliably verifying the absence of microorganisms in the product is the so-called tank storage test (i.e. storage of heat-treated product in a sterile aseptic tank; any microorganisms still present will multiply and completely spoil the product and so easily demonstrate the unsterility of such spoiled product).

• Check of packaging According to the machine manufacturer's recommendations.

• Finished product Recommendation for aseptic filling: immediately after the start of production, and then every 30/60 minutes: 2 samples; additionally, 12 retained samples per production batch (beginning, middle, end of production), possibly as control samples in the case of claims or complaints; additionally, at least 2 samples after machine stop. All half-hourly and hourly samples as well as special samples are incubated at suitable temperatures for suitable incubation periods (e.g. at 30 °C for 3 days) and microbiologically tested. The retained samples are kept at ambient temperature or at chilled temperatures until the end of the declared product shelf life.



Keywords Notes 7.2 Check of package

• Visual inspection of package (evaluation of appearance)

• Check of sealing areas • Leakage test (visual evaluation, ink test,

conductivity measurement) • Weight and volume check

To identify machine malfunctions as early as possible, simple tests should be carried out by the machine operator during sampling.

7.3 Testing the finished product • Test for residues of sterilization agent in the

product • Microbiological examination of product filled

into package • Physicochemical analysis of filled product

To identify machine malfunctions as early as possible, simple tests should be carried out by the machine operator during sampling.

7.4 Identification of sporadic faults The reliable identification of sporadic faults in the microbiological functions of aseptic packaging machines on the basis of random sampling is virtually impossible. For instance, to confirm a desired commercial unsterility rate of 0.1%, a sample size of 3,000 samples per machine would be necessary in order to demonstrate a malfunction statistically with a probability of 95%. The systematic capture and analysis of complaints has proved to be a useful instrument in practice for identifying causes of faults.



8 Quality-maintenance measures in the event of operating malfunctions Aseptic packaging machines are equipped with extensive control functions to ensure, as a rule, that the machine is shut down in the event of technical faults or disturbances and that production cannot be resumed until the cause of the fault has been eliminated and the performance of specified further measures to ensure product safety has been acknowledged. At the same time the state of the machine at any moment (ready for operation, not ready for operation, sterile, unsterile …) should be displayed to the machine operator. Despite all the precautionary measures in the technical field it cannot be fully excluded that cases of unsterility, for example, occur. Accordingly, as a precaution it is recommended that instructions for emergency action be drawn up to prevent unsterile production batches being marketed or at least to limit the selling on of already shipped batches to an unavoidable minimum. Furthermore, instructions for action should be issued which promote quick troubleshooting. Employees should be trained in the instructions for action affecting them so that they are not confronted with an unknown situation in a case of emergency. The instructions for action should also include careful documentation of fault or failure events. This documentation serves for analyzing the cause of the fault and can be used as the basis of a weakness analysis to prevent future failures. It is recommended to proceed as suggested even in the case of nonaseptic filling to restrict the risk of marketing of products that are posing a risk to health and that are not in line with quality standards to an unavoidable level. Keywords Notes 8.1 Potential hazards

• physical (e.g. glass splinters) • chemical • microbiological

A hazard analysis should be performed for the various types of potential hazards so that the risk for the consumer may be assessed.

8.2 Recommended actions in the event of a fault

In the case of aseptic filling the instructions for action should limit the health risk to the consumer to an acceptable residual risk.

• For the reliable identification of a fault or failure

• For identifying the cause of the fault or failure

The sampling plan before and during production should be suitable for narrowing down the causes of faults.(see Chapter 7.1)

• For troubleshooting • To prevent marketing of products that are

unsterile and in the case of nonaseptic filling products that are not in line with quality standards

For example production batches should be unambiguously identified (batch, production line, date of production, batch identification)

• For documenting the fault or failure • For starting up after a fault or failure Where necessary, the machine is to be cleaned and sterilized (see Chapter 10).



Keywords Notes 8.3 Documentation

• Machine operator • Type of fault or failure • Duration of fault or failure • Action for eliminating the fault • Action for holding back unsterile packages • Cleaning/sterilization • Clearance to resume production • Remaining actions

8.4 Training



9 Maintenance measures Maintenance covers measures for retaining and restoring the desired state of the machine. This includes:

• Maintenance work to be performed regularly according to a specified schedule in order to retain the functional capability of the machine • Inspections to assess the actual condition of parts and components of the machine which are subject to wear • Corrective maintenance work for repairing or replacing defective or worn or obsolete parts and components

It is worthwhile to aim for preventive maintenance, incorporating inspections and corrective maintenance into regular maintenance activities, in order to recognize and correct weak points reliably before the plant fails. This objective can also be achieved through regular checks of the complete system independently of any damage events. The preventive nature of maintenance is all the more important in aseptic packaging machines as any maintenance work performed inadequately or too late may result in unsterility. In practice, the following have proved to be particularly critical aspects:

• nonobservance of specified maintenance cycles • fitting of parts not conforming to specification • Use of operating resources not conforming to specification • Use of overaged elastomers16 • Use of immature elastomers

The background to such maintenance shortcomings in production companies often takes the form of cost-cutting exercises or a conflict between production targets and maintenance requirements. This ever-present conflict of objectives between a reliable product and cost-effective production should be taken into account in particular when responsibilities are assigned.

16 Elastomers: Rubber-like materials; e.g. gaskets/seals and membranes



Keywords Notes 9.1 Organizational measures 9.1.1 Responsibilities

Assignment of responsibility for: • maintenance specifications in accordance

with operating & maintenance instructions • maintenance plan • operations planning • performance of maintenance and corrective

maintenance work • check of performance • release for production after maintenance or

corrective maintenance • amendments to maintenance plan

9.1.2 Maintenance plan • What ? • Who ? (Responsibilities, necessary

qualifications) • How ?

How often ?

The maintenance plan includes the complete range of maintenance operations. It makes reference to the instructions for action for the individual maintenance and inspection tasks. These, in turn, include information about: • measurement variables, test and calibration values including allowed deviations • required measuring, inspection and calibration equipment17

• special tools needed • attachment points • weights • operating resources and auxiliaries required • reference to particular hazard sources (such as corrosive liquids, components subjected to heat,

pressure or stress, etc.) • safety equipment and safety measures • required personal safety equipment • supplementary documentation (e.g. circuit diagrams, exploded diagrams, overview of inspection and

maintenance points, lubrication instructions, list of parts subject to wear, etc.)

17 Calibration equipment: Instruments for measuring correct dimensions



Keywords Notes 9.1.3 Operations planning

• Service personnel • Materials • Freeing of machine

Inadequate operations planning is often the cause in practice of unnecessarily prolonged downtimes or incorrectly conducted maintenance.

9.1.4 Documentation • What has been done? • By whom has it been done and with what

result? • What remains to be done, by when must it

be completed, and who is responsible for this?

Careful documentation of maintenance and corrective maintenance is an important source of information when searching for faults in cases of unsterility or when quality problems arise. Moreover, the documentation provides a basis for the regular updating of the maintenance plan and maintenance instructions.

9.1.5 Updating of the maintenance plan • Why has it been amended? • Who may amend? • Documentation of changes? • Systematic information gathering and

evaluation as a basis for updates.

The maintenance plan and maintenance instructions should be reviewed at regular intervals and should be updated as a function of empirical data and if necessary be adapted to modified production sequences. Updates should be coordinated with the machine manufacturer.

9.2 Operating materials and spare parts • Availability • Agreement with specifications specified by

the machine manufacturer • Storage (specification of storage conditions,

adherence to storage times, especially important for elastomers)

• Documentation

Where the specification of operating materials and spare parts is altered, agreement is necessary with the machine manufacturer concerning any possibly essential amendment of the maintenance instructions. Notes on the specification of elastomeric sealing materials have been published by the VDMA Technical Association for Processing Machinery and Equipment18

9.3 Cleaning / Sterilization After any maintenance or repair activities affecting the aseptic section of the machine, the machine must be cleaned and subsequently sterilized as a matter of principle.

9.4 Sterile test19 • When is a sterile test required? • What does this test cover? • Documentation

In accordance with the machine manufacturer's instructions. If any changes are made to the sterile system or to product-carrying parts of the packaging machine or in the case of changes in the process section of the overall plant, a sterile test in accordance with the manufacturer's specification is recommended before starting up the machine.

18 VDMA, FV VtMA (2005): Elastomeric sealing materials for near-aseptic or sterile process technologies – Supply specification; available at no cost via www.vdma.org 19 With regard to the sterile test see also VDMA Document FS NuV No. 12/2007



10 Cleaning/Sterilization The following comments were formulated for filling machines of hygiene classes IV and V. They can be extended with appropriate modifications to machines of hygiene class I-III. Keywords Notes

10.1 Cleaning and sterilizing the aseptic packaging machine • Flow rates • Temperatures • Concentrations • Cleaning times • Cleaning cycles • Inspection of cleaning result • Cleaning intervals • Sterilization times • Sterilization cycles • Sterilization intervals • Inspection of filters (especially sterile filters) • Cleaning of supply lines and sterilization

systems

Filling machines of hygiene classes IV and V are usually equipped with CIP (cleaning in place) systems and SIP (sterilization in place) systems. A long-term satisfactory cleaning and sterilization result presupposes that the cleaning and sterilization intervals20 as well as the maintenance work and intervals determined by the manufacturer are observed. It should be pointed out in particular that the duration and frequency of cleaning depend on the cleaning agent used and the product to be filled. Accordingly, when the cleaning agent is changed, the settings for CIP cleaning and, where applicable, the prescribed cleaning frequency must also be changed. These variations should be agreed with the machine manufacturer. It is further pointed out that the cleaning agent used has an effect on the wear of elastomers and the corrosion of product-handling parts. When choosing cleaning agents attention should be paid to the lowest possible adverse effects. Cleaning should be carried out in such a way that a successful result can be achieved for low resource consumption. Where a new product is to be filled the necessary cleaning program should be agreed with the machine manufacturer.

20 Cleaning cycle: 1 cycle = 1 pass through the corresponding program Cleaning interval: Period of time between cleaning operations



Keywords Notes 10.2 Unscheduled cleaning or sterilization

• After extended breaks in production • After operational faults affecting the sterile

section of the packaging machine • When there is deteriorating quality of

cleaning

In addition to the nonobservance of cleaning, sterilization or maintenance standards, cases of unsterility may occur in practice primarily because of the following cleaning problems: • gradual formation of deposits on product-handling parts • increased soiling after extended downtimes • increased surface roughness of product-handling parts due to corrosion Owing to these potential faults or failures which may arise despite adherence to the cleaning specifications, a regular review of cleaning results is recommended, e.g. by an examination of the last flushing water used or by means of UV illumination which can reveal deposits. In the event of deteriorating quality of cleaning, appropriate instructions for action are to be issued which will ensure adequate cleaning and will initiate necessary maintenance operations.

10.3 Cleaning documentation Contents: • Who ? • When ? • What ? • With what result ?

Sets of documentation are an indispensable source of information for the next machine operator in shift operation. Automatic cleaning documentation package is recommended for filling machines of classes IV and V.



11 Documentation Reliable sets of documentation are an indispensable aid for avoiding faults or failures in the production workflow and for identifying the cause of faults in the event of product complaints. As a rule documentation should show who carried out which tests according to which instructions and with what degree of excess. Extraordinary events should be noted separately. Any action initiated for the correction of faults or otherwise should also be recorded. In doing so responsibilities and completion times should be mentioned and successful completion recorded. Keywords Notes 11.1 Documentation of tests carried out

prior to production

Subject of tests: see Chapter 4

11.2 Documentation of tests carried out during and after production

Subject of tests: see Chapter 5 and 6

11.3 Cleaning documentation Subject of tests: see Chapter 10 11.4 Documentation of tests carried out for

subsequent quality control of the finished product and packaging

Subject of tests: see Chapter 7

11.5 Documentation of operating malfunctions

see Chapter 8

11.6 Systematic recording of customer complaints

11.7 Documentation of maintenance and repair measures undertaken

see Chapter 9

11.8 Change documentation • Test lists for tests before, during and after

production • Test plans for checking the quality of finished

products and packaging • Maintenance plans • Cleaning and sterilization instructions



12 Training 21 Practical experience has shown that aseptic production can hardly be guaranteed without adequate staff training. Accordingly, training of all groups of people involved in aseptic production, including management, is urgently recommended. The contents of the training program should be differentiated according to the specific requirements of the respective target groups. In addition to basic training, regular refresher courses are recommended. In nonaseptic filling of microbiologically sensitive products staff training in hygiene is unreservedly advisable. With regard to details of a training program for hygienic filling we refer readers to VDI-Richtlinie 4066 and DIN 10514. Typical key-words of a training program are listed below. Training should be conducted in both theory and practice. 12.1 Machine staff

Basic course for machine operators • Instruction in safety • Basic concepts of hygiene • Preparation and performance of sterilization • Production • Cleaning including external cleaning • Setting values and checking them • Daily/weekly maintenance • Packaging inspection, dating • Basic information about operating resources • Fundamentals of documentation • Response to operating faults (see 8.2)

Continuation course for machine operators • Instruction in safety • Extended hygiene information • Extended packaging assessment • Basic concepts of hydraulics and pneumatics • Fault identification and elimination in the mechanical field • Preventive safeguarding of the machine hygiene standard • Checking on operating resources

21The need for hygiene training is indicated, for example, in EC Ordinance 852/2004 in relation to food hygiene in Appendix II, Chapter XII. There it is stated: “Operators of food companies ensure that persons handling foodstuffs are monitored in accordance with their activity and are instructed and/or trained in question of food hygiene.” In aseptic production awareness creation going beyond “normal” training is appropriate.



12.2 Maintenance staff

Basic course "Maintenance I" • Basic course in hygiene • Instruction in safety • Setting values and dimensions • Maintenance work according to maintenance instructions • Preventive maintenance according to listings • Fault-finding and repair in the mechanical field • Basic information about pneumatics and hydraulics

Basic course "Maintenance II" • Instruction in safety • Control dimensions and special settings • Inspections • Extended packaging assessment • Complex fault finding and elimination • Extended information about pneumatics and hydraulics • Basic information about electrical engineering

12.3 QA (quality assurance) staff

Special course "Quality control" • Microbiology • Checks on operating resources • Weight checks • Statistics • Laboratory checks • Return flow analysis • Troubleshooting in the event of unsterilities

12.4 Management staff

Special course for technical management • Basic course in hygiene • Process workflows • Production organization • Personnel deployment • Quality assurance • Warehousing and storage • Room layout • Waste disposal • Legal regulations



13 References

DIN 8743: 2004-06 Packaging machines and packaging systems – Time-related terms, characteristic variables and fundamentals of calculation DIN 8782: 1984-05 Drinks filling technology: Terms for filling plants and individual units DIN8783: 1986-07 Drinks filling technology: Investigations of industrial filling plants DIN 8784: 1993-11 Drinks filling technology: Minimum data and order-related data DIN ISO 9000: 2005: Quality management systems – Fundamentals and terms DIN 11483 Part 1 (1983-01 edition): Milk industry plants: Cleaning and disinfection: Taking account of the effects of stainless steel DIN 10514, 2004-05: Food hygiene – Hygiene training EC Ordinance No. 852 (2004) on Food Hygiene: Official Journal of the European Union L226 of 25.6.2004 EHEDG Subgroup Packing Machines (2000): Challenge Tests for the Evaluation of the Hygienic Characteristics of Packing Machines, EHEDG Document No. 21; order via www.ehedg.org Erhitzerausschuß [Heater Committee] (1982): Test Guideline No. 3: Type testing of aseptic packaging machines for UHT milkfor the purpose of official approval; Kieler Milchwirtschaftliche Forschungsberichte 34, 409-414 (1992) Hennlich, Dr. W. (2004): Guide values for food packaging – Microbiological assessment of nonabsorbent packaging materials and packaging, Verpackungsrundschau 12/2004, Technisch-Wissenschaftliche Beilage (Technical Supplement) 55 VDI 4066: Guidelines for hygienic filling (in preparation) VDMA, FV VtMA (2005): Elastomeric sealing materials for near-sterile or sterile process technologies – Supply specification Frankfurt, March 2005, available as download from www.vdma.org/verfahrenstechnik VDMA FV NuV, Frankfurt 2000 VDMA Documents Food Processing Machinery and Packaging Machinery 2000/No. 1 Two methods for checking the determination of residual peroxide in empty cups at the filling machine – Test procedures VDMA FV NuV, Frankfurt 2000 VDMA Documents Food Processing Machinery and Packaging Machinery 2000/No. 4 Aseptic production lines: Unsterility hazards in product and operating resource lines – Planning and installation errors VDMA FV NuV, Frankfurt 2000 VDMA Documents Food Processing Machinery and Packaging Machinery 2000/No. 2 (2nd edition 2006) “Hygienic filling machines for liquid and pasty foods – Categories and typical fields of application”, (2nd edition 2006) VDMA FV NuV 2002 (revised version 2008) VDMA Documents Food Processing Machinery and Packaging Machinery 2002/No. 6 (revised version 2008) Code of practice – Testing the effectiveness of aseptic systems incorporating packaging sterilization equipment VDMA FV NuV, Frankfurt 2003



Code of practice- Testing aseptic systems: Sterilizing the sterile section in the interior of the machine VDMA Documents Food Processing Machinery and Packaging Machinery No. 8 VDMA FV NuV, Frankfurt 2005 Hygienic filling machines of VDMA class IV for liquid and pasty foods – Minimum requirements and boundary conditions for a operations in line with regulations VDMA Documents Food Processing Machinery and Packaging Machinery No. 10 VDMA FV NuV, Frankfurt 2006 VDMA Documents Food Processing Machinery and Packaging Machinery No. 11 Aseptic packaging machines for the food industry: Minimum requirements and boundary conditions for operations in line with regulations, as replacement for VDMA 8742 VDMA FV NuV, Frankfurt 2007 VDMA Documents Food Processing Machinery and Packaging Machinery No. 12 Guide to testing the microbiological safety of filling machines of VDMA hygiene classes IV and V VDMA FV NuV, Frankfurt 2006 Code of practice – Testing hygienic filling machines of VDMA class V (aseptic filling machines) – External sterilization of packaging units VDMA Documents Food Processing Machinery and Packaging Machinery No. 14 All VDMA documents are available as download in German and English from www.vdma.org/packtech



Appendix: Hygienic filling – Summary of factors relevant to quality Product Packaging Filling machine/system To be borne in mind in planning

Establish the requirements of the product to be filled: • physical constitution • hygiene requirements

(microbial. quality, desired shelf life, planned distribution channel

• mixed operation: sterile and unsterile products?

Establish packages to be filled (container sizes, geometries, if need be type of closure) Requirement of packages: • inter alia with respect to

sterilizability

Capacity / Layout Laying down VDMA hygiene classes Hygiene requirements imposed on the environment of the machine location Space required Accessibility Connection levels for operating resources Legal requirements

… before and during start-up

Draw up sampling plan Draw up procedural instructions for product tests

Check the suitability of packaging and packaging auxiliaries for planned packaging sterilization (when filling on filling machines of hygiene classes IV and V)? If need be requirements on maximum microbial loads on the packaging employed. Draw up specification Draw up procedural instructions for packaging tests

Environment of machine location (if need be correction of installation and planning errors prior to installation of machine Testing connection values Checking proper installation of filling machine Functional tests (ending with test run) Checks on microbiological functions (microbiological challenge tests) for filling machines of hygiene classes IV and V Sterile test (hygiene classes IV and V) for clearance of the filing machine for commercial production Check on compliance with legal threshold values (airborne noise, electromagnetic compatibility (EMC), waste water, workplace limits) Test production to check contractually agreed performance pledges Check on reliable exclusion of hazards identified in the course of a hazard analysis previously carried out Drawing up procedural instructions for cleaning, sterilization, maintenance and servicing Hygiene training (operating staff, maintenance staff, management) Preparation of procedural instructions for operating faults (for filling machines of hygiene class V); staff training with regard to this



Product Packaging Filling machine/system … before start of production

Clearance of product for filling after checking its properties relevant to hygienic filling as per the procedural instructions

Testing as per procedural instructions for fit with specification Correct storage? Delivery of packaging and packaging auxiliaries to the machine (if necessary paying attention to temperature control and atmospheric humidity) Visual inspections for damage and soiling If necessary testing empty packs for residues of sterilizing agent If need be deionize packaging webs

Testing operating resource media for correct connection, quality in conformity with specification and amount provided: • electricity supply • cooling/flushing water • ice water • steam • compressed air • sterilizing agent • cleaning agent Testing for proper performance of maintenance and servicing work Cleaning and if need be sterilization of filling machine and check on their proper completion as per procedural instructions; in doing so adherence to maximum allowable concentrations with respect to sterilizing agents employed Check on machine functions critical for hygienic production (automatic self-testing or as per procedural instructions)

… during production Removal of sample packages as per sampling plan

Performance of simple packaging tests in course of sampling by the operator at the machine for the rapid identification of faults

Check on all key operating parameters (automatic self-check or as per procedural instructions) Adherence to maximum allowable concentrations with respect to sterilizing agents employed Observance of procedural instructions in the event of production stoppages Observance of procedural instructions in the event of operating faults



Product Packaging Filling machine/system … after end of production

Laboratory tests on finished product

Precautionary measures against soiling of packaging (e.g. covers and if need be storage)

Machine inspection • Read off and document filling levels of operating resources • Establish consumption levels • If necessary waste disposal of operating resources

Cleaning/sterilisation • Product-handling parts • Machine interior • External cleaning and if need be disinfection • Cleaning of the machine environment

Documentation • Cleaning/sterilization • Production log

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